Qc Analytical Transfer Technologist Quality Control 6 Month Contract-day Shift
Therapure Biopharma Inc. is a biopharmaceutical company focused on complex biological therapeutics and technologies. It is comprised of three divisions: Therapure Biomanufacturing which provides contract development and manufacturing (CDMO) services to global clients; Therapure Innovations, focused on research and development of proprietary therapeutics and platform technologies in the areas of anaemia, liver disease and organ preservation; and Therapure Biologics dedicated to the development of plasma protein therapeutics through an innovative proprietary manufacturing technology.
We are growing! In fact, from 2014 to 2016, we were recognized by Profit 500 as one of Canada’s Fastest Growing Companies.
Responsible for execution of transfer, qualification, validation and verification protocols according to cGMP and company specifications. Responsibilities also include preparation of reports, instrument and material sourcing and training QC technologists on new and modified procedures.
Here is what we are looking for:
- Bachelor’s degree in a scientific discipline with at least 3 years related experience in a quality lab environment (pharmaceutical preferred), or M.Sc./Ph.D. with one year quality lab environment
- Strong understanding of GMP is an asset
- Thorough understanding and ability to interpret regulatory requirements.
- Certificate in regulatory affairs will be considered an asset
- Knowledge of compendial test requirements, US and Europe Pharmacopeia is an asset
- Strong analytical and statistical analysis skills
- Extensive knowledge and practical experience in protein analysis such as BCA, Western blot, SDS-PAGE, ELISA, potency and functionality cell-based assays SEC-HPLC, and concentration analysis using UV-Vis Spectrophotometer. Experience using Octet or other similar technologies will be considered an asset.
- Knowledge and experience with analytical instrumentations (e.g. HPLC, Plate readers, UV spectrometers,)
- Data analysis, statistics and report preparation with knowledge of MS Word, Excel and Outlook
Here is what you will be responsible for (but not limited to):
- Execute transfer, qualification, verification and validation of analytical methods used for release and stability testing of biopharmaceutical products
- Analyse results utilizing statistical tools where required
- Prepare transfer, verification and qualification/validation reports, and revise analytical test methods when required.
- Review and analyse clients’ procedures, validation reports and other related documentation to assess method’s feasibility and readiness for GMP environment. Prepare comprehensive summary of findings.
- Review, revise and implement standard operating procedures to meet the regulatory compliance targets and objectives. Apply up-to-date knowledge in various analytical techniques (ELISA, SDS PAGE, BCA, UV Vis).
- Stay abreast of the recent regulatory requirements – ICH, FDA, Health Canada, Med Device - and industry practices pertaining to analytical method validation, stability and product release for biopharmaceutical.
- Ensure that all work is performed in compliance with company Safety policies, Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs)
- Perform training of the QC laboratory technologists on new transferred and/or revised analytical procedures
- Perform routine maintenance on laboratory instruments
- Troubleshoot methods and equipment as required
- Follow established procedures for chemical receipt, inventory, use and discard.
- Employ good documentation practices when generating raw data, reports, SOPs and other documentation.
- Participate in lab investigations with supervisor.
- Report to supervisor any deviations from company procedures, or other discrepancies that may affect product quality or cGMP status according to established procedures.
Interested candidates can send their resume and cover letter to firstname.lastname@example.org. Please reference QC Biochemistry Technologist Level II (Afternoon Shift) in the subject line. While we appreciate all interest in this opportunity, only qualified candidates will be contacted.
Therapure Biopharma Inc. will not be responsible for any agency referral fees arising from the use of resumes that currently exist in the recruitment database or have been forwarded to Therapure Biopharma directly or indirectly without an authorized agreement. Agency referrals will not be accepted unless approved by the Therapure Biopharma Inc. Human Resources team.
NOTE:All employment is conditional upon the completing and obtaining a satisfactory background check, including pre-employment medical (where applicable), educational, employment, references and criminal records (for which a pardon has not been granted) checks.
Therapure is committed to providing accessible employment practices that are in compliance with the Accessibility for Ontarians with Disabilities Act (AODA). Requests for accommodation can be made at any stage of the recruitment process, applicants are asked to make their needs/requirements known. Please notify Human Resources at HR@therapurebio.com for assistance.